In this free webinar, learn how medical devices benefit from modern digital validation strategies. Attendees will learn how digital validation builds confidence and removes redundancy. The featured ...

Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA?

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Brendan Carroll, Jessica Ritsick, Jong Ho "Philip" Won, Ph.D. Our FDA: Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...